APPENDIX B

GENERAL OPERATIONS CHECKLIST

NIST Handbook 150-18 B-1 , August 1996


vvrvyy

NVLAP LAB CODE:

(4)

(5)

(6)

Particular care and attention shall be paid to the arrangement of the
certificate or report, especially with regard to presentation of the calibration
or test data and ease of assimilation by the reader. The format shall be
carefully and specifically designed for each type of calibration or test carried
out, but the headings shall be standardized as far as possible [see also
(k)(1)1.

Material amendments to a calibration certificate, test report or test certificate
after issue shall be made only in the form of a further document, or data
transfer including the statement "Supplement to Calibration Certificate (or
Test Report or Test Certificate), serial number ... (or as otherwise
identified)," or equivalent form of wording. Such amendments shall meet all
the relevant requirements of item (j).

The laboratory shall notify clients promptly, in writing, of any event such as
the identification of defective measuring or test equipment that casts doubt
on the validity of results given in any calibration certificate, test report, or
test certificate or amendment to a report or certificate.

NOTE: Such notification shall quantify the magnitude of error created in the
calibration results. The laboratory shall notify customers promptly, in
writing, of any customer’s measuring and test equipment found significantly
out of tolerance during the calibration/verification process. Measurement
data shall be reported so that appropriate action can be taken.

NIST Handbook 150-18 B-23 August 1996


NVLAP LAB CODE:

(3) The laboratory shall have documented procedures and appropriate facilities
to avoid deterioration or damage to the calibration or test item, during
storage, handling, preparation, and calibration or test; any relevant
instructions provided with the item shall be followed. Where items have to
be stored or conditioned under specific environmental conditions, these
conditions shall be maintained, monitored and recorded where necessary.
Where a calibration or test item or portion of an item is to be held secure (for
example, for reasons of record, safety or value, or to enable check
calibrations or tests to be performed later), the laboratory shall have storage
and security arrangements that protect the condition and integrity of the
secured items or portions concerned [see also (e)].

(4) The laboratory shall have documented procedures for the receipt, retention or
safe disposal of calibration or test items, including all provisions necessary to
protect the integrity of the laboratory.

(5) Tamper-resistant seals shall be affixed to operator-accessible controls or
adjustments on measurement standards or measuring and test equipment
which, if moved, will invalidate the calibration. The laboratory's calibration
system shall provide instructions for the use of such seals and for the
disposition of equipment with damaged or broken seals.

NOTE: Tamper-resistant seals are sometimes affixed to equipment to
prevent unauthorized access to areas where adjustments or critical
components are located.

NIST Handbook 150-18 B-19 August 1996


v

vvvvYVYVYVYVYVYVYv vv vv vv vv VV VV VV vv VV VY

NVLAP LAB CODE:

(o) Measuring and test equipment (M & TE)

(1)

{i)

(ii)

(iii)

(iv)

(v)

NOTE: This section applies to the control of measuring and test equipment
{M & TE) used to assure that supplies and services comply with prescribed
customer requirements. It is based in large part on the requirements found in
government audit standards such as MIL-STD 45662A, and is found in Part Il
of the ANSI/NCSL Z2540-1-1994 (Draft) standard.

General requirements for M & TE

The supplier shall establish and document a system to control the
calibration/verification of M & TE.

M & TE used to determine compliance with customer technical specifications
shall be calibrated or verified in accordance with sections 285.33(b) through
(n).

The supplier shall have a program to recall for calibration or verification, or
remove from service, M & TE that has exceeded its calibration interval, has
broken calibration seals, or is suspected to be malfunctioning because of
mishandling, misuse, or unusual results.

All operations performed by the supplier in compliance with these
requirements shall be subject to customer verification at unscheduled
intervals.

The supplier shall carry out, or arrange to have carried out, periodic quality
auditing of the calibration and verification system in order to ensure its
continuing effective implementation and compliance with these requirements.

- Based on the results of the audits and any other relevant factors, such
as customer feedback, the supplier shall review and modify the system
as necessary.

-1) Plans and procedures for the audits shall be documented. The conduct
of the audit and any subsequent corrective action shall also be
documented.

NIST Handbook 150-18 B-28 August 1996


@

)

written procedures to address the necessary
processes.

Handling of calibration and test items

(1) The laboratory shall have written
procedures covering all aspects of receipt,
handling and storage of test items. The log-in
system shall include documentation of the date
of receipt, identity of the client, unique
identification for the sample, condition of the
samples, and the acceptance or rejection of the
samples. The laboratory shall have written
criteria for acceptance or rejection of samples.

(2) The laboratory shall have a chain-of-
custody system that documents the following
information:

@ location of the sample;

(ii) personnel who have handled or
worked with the sample; and

iii) what has been done to the sample.

The system for identifying samples to be tested

” must remain in force from the date of receipt of

the item to the date of its disposal, either
through documents or through marking, to
ensure that there is no confusion regarding the
identity of the samples and the results of the
measurements.

Records (see Specific Operations Checklist)

Records may be kept in hard copy or computer form
(with an adequate back-up system), but they shall be
readily accessible and secure. The period of
retention shall be 5 years, unless a longer period is
required by the client, regulation, or the laboratory’s
own procedures. Procedures for storage and retrieval
of records must be documented and maintained in the
laboratory’s quality system documentation. Records
shall be stored in a logical fashion allowing retrieval
within one working day.

(k) Certificates and reports

(1) Test reports issued under the requirements
of the Fastener Quality Act shall be in English
or be translated into English, signed by an
approved signatory, and be protected by a
tamper-resistant system. In addition to the
requirements found in Sec. 285.33(k) of NIST

Handbook 150, the test report shall also include
the following information:

@ Fastener description, including:

© Manufacturer (name and address);

© Product family (screw, nut, bolt,
washer, or stud), drive and/or head
configurations as applicable;

¢ Date of manufacture;

° Head markings (describe or draw
manufacturer’s recorded insignia
and grade identification or property
class symbols);

¢ Nominal dimensions (diameter;
length of bolt, screw or stud;
thickness of load bearing washer or
nut); thread form and class of fit;

¢ Product standard and specification
related to the laboratory in writing
by the manufacturer, importer or
distributor;

© Lot number and other numbers as
appropriate;

© Specification and grade of material;

¢ Coating material and standard and
specification, if applicable.

(ii) Sampling information:
¢ Standard or reference for sampling
scheme;
© Production lot size and the number
sampled and tested;
¢ Name and affiliation of person
performing the lot sampling.

iii) Test results:

° Actual tests required by standard
and specification;

© Test results for each sample;

* All deviations from the test
method;

e All other items required on test
reports according to the test
method;

¢ Where the report contains results of
tests performed by subcontractors,
these results shall be clearly
identified along with the name of
the laboratory and accreditation
information listed in item (v) of this
section.

¢ A statement that the samples tested
either conform or do not conform
to the fastener standard and
specification and explanation of any

NIST Handbook 150-18

August 1996


NVLAP LAB CODE:

10.2.3 The name, title and signature of Approved Signatory accepting
technical responsibility for the tests and test report.

10.2.4 The name of the body which accredited the laboratory (i.e., NVLAP)
for the specific tests performed which are the subject of the report,
NVLAP Lab Code assigned to the laboratory, and the expiration of
accreditation.

10.3 The laboratory uses a tamper-resistant system to protect test reports.
11 Subcontracting of calibration or testing

11.1 Testing conducted under the requirements of the Fastener Quality Act (FQA) is
subcontracted to a laboratory that is accredited under the provisions of the FOA
regulations.

12 Outside support services and supplies
(See General Operations Checklist.)
13 Complaints
(See General Operations Checklist.)
14 Proficiency testing

14.1 The laboratory shall participate in the mandatory NVLAP Proficiency Testing
program, which includes (but is not limited to) the following:

14.1.1 analyses are not contracted out to another laboratory;

14.1.2 laboratory keeps and utilizes proficiency testing materials for use as
in-house instructional materials;

14.1.3 one single result is reported back to NVLAP, or its contractor, by the
laboratory unless otherwise specified in the testing instructions;

14.1.4 plans are developed and implemented for resolving problems and are
documented; and

14.1.5 copies of proficiency testing reports, and data sheets are maintained
for a minimum of 5 years.

NIST Handbook 150-18 C-7 August 1996


NVLAP LAB CODE:

can be analyzed by the laboratory), the laboratory shall have a procedure for informing
the client and resolving the problem. This action shall be documented.

9 Records

9.1 The laboratory's quality system documentation shall have written procedures for
the storage and retrieval of records.

9.2 Records are stored in a logical fashion allowing retrieval within one working day.

9.3 The laboratory shall have documentation, either electronic backup or "paper" hard

copy, to verify survival of original data if computers are used for data retention.

data.

9.5.1
9.5.2
9.5.3
9.5.4
9.5.5
9.5.6
9.5.7
9.5.8

9.4 The laboratory shall ensure that the analyst signs (or initials) and dates the original

9.5 The following records are maintained for a minimum of 5 years:

sample custody;

original data collected by analyst;

identity of personnel involved in sample preparation and testing;
calibration and verification data;

quality control activities and results;

equipment and maintenance;

test reports; and

records of all actions taken in response to testing complaints.

10 Certificates and reports

10.1 In addition to the requirements in the General Operations Checklist, each test

report shall include the following information:

10.1.

1

Fastener description, including:

manufacturer (name and address);

product family (screw, nut, bolt, washer, or stud), drive and/or head
configurations as applicable;

date of manufacture;

head markings (describe or draw manufacturer's recorded insignia and
grade identification or property class symbols);

nominal dimensions (diameter; length of bolt, screw or stud;
thickness of load bearing washer or nut); thread form and class of fit;
product standard and specification related to the laboratory in writing
by the manufacturer, importer or distributor;

lot number and other numbers as appropriate;

specification and grade of material;

coating material and standard and specification, as applicable.

NIST Handbook 150-18

C5 August 1996


NVLAP LAB CODE:

NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM

ON-SITE ASSESSMENT - TEST METHOD REVIEW

Instructions to the Assessor:

During the on-site visit you will be required to assess the laboratory’s ability to conduct the
specific test methods for which it has applied for accreditation. In some cases this will involve
many test methods. You may not have sufficient time to perform an in-depth assessment of
each method.

Use the attached sheets to indicate which test methods you assessed at the laboratory, and
the extent of your assessment. Indicate whether you performed an in-depth review, including
a full review of laboratory activities. These include sample control and preparation, procedure
review, observation of actual testing, environmental control check, equipment review,
calibration checks, record-keeping practices and report forms; or, that you observed selected
items to determine that the laboratory demonstrated the ability to conduct the test.

Fill out the ON-SITE ASSESSMENT - TEST METHOD REVIEW SUMMARY by writing in the test
method designation. All test methods should be given the greatest depth of assessment that
time and practicality allow. Indicate on the summary the DEPTH of the assessment for each
test method you reviewed, using one of the symbols shown below:

OT - (Observed Test)

EA - (Examined Apparatus)

WITT - (Walked/Talked Through)

LDP - (Listened to Description of Procedures)

For the remaining categories, mark each with an "X" if a deficiency is identified, a "C" if you
wish to make a comment, or a "“" if all requirements have been met. All deficiencies must
be accompanied by a comment.

Use the ON-SITE ASSESSMENT - TEST METHOD REVIEW COMMENTS AND DEFICIENCIES
sheets to write comments on what you observed. Preface each comment with the test
method designation to which the comment applies. Please be liberal with your comments so
that we have a good written record of your observations; the more information we have, the
better the accreditation decision we can make.

Special Instruction:

NIST Handbook 150-18 D-3 August 1996


FASTENERS AND METALS PROGRAM
MAJOR AREAS OF TESTING

1. MECHANICAL AND PHYSICAL TESTING AND INSPECTION

1.1 Aerospace nut tests

1.1.1 Flareability test of clinch and shank nuts

1.1.2 Permanent set test of self-locking nuts

1.1.3. Push out test of floating plate nuts, gang channel nuts, and anchor nuts

1.1.4 Reusability test of self-locking internally threaded fasteners

1.1.5 Room temperature of three cycles test of floating plate nuts, gang channel nuts and
anchor nuts

1.1.6 Torque-out test

1.1.7 Wrench torque test of externally wrenched nuts of spline and hexagon and double
hexagon (12 point) wrenching configuration

1.2 Adhesion

Adhesion of metallic coatings on fasteners

1.3 Bend

Bend test of full size eyebolts

1.4 Coating/plating thickness

1.4.1
1.4.2
1.4.3
1.4.4
1.4.5
1.4.6
1.4.7
1.4.8

Measurement of fastener coating thickness - eddy-current method
Measurement of fastener coating thickness - magnetic methods
Measurement of fastener coating thickness - microscopical method
Measurement of fastener coating thickness - weight of coating
Measurement of fastener coating thickness - beta backscatter method
Measurement of fastener coating thickness - coulometric method
Measurement of fastener coating thickness - dimensional change method
Measurement of fastener coating thickness - X-ray methods

1.5 Corrosion

1.5.1
1.5.2
1,5.3
1.5.4

1.5.5

1.5.6
1.5.7

1.5.8

Salt spray testing of fasteners

Humidity testing of fasteners

Stress corrosion of fasteners

Intergranular corrosion susceptibility in austenitic stainless steel fasteners - nitric
acid test

Intergranular corrosion susceptibility of austenitic stainless steel fasteners - oxalic
acid etch test

CASS test (copper-accelerated acetic acid-salt spray test) of fasteners

Water immersion test - test for anodic surface contaminants on corrosion resistant
fasteners

Copper sulfate test - test for free iron on the surface of corrosion resistant fasteners

NIST Handbook 150-18 E-3 August 1996


NVLAP LAB CODE:

FASTENERS AND METALS SPECIFIC OPERATIONS CHECKLIST

Instructions to the Assessor: This checklist addresses specific accreditation criteria prescribed
in applicable sections of NIST Handbook 150-18.

Place an "X" beside any of the checklist items which represent a deficiency. Place a "C"
beside each item on which you are commenting for other reasons. Record the item number
and your written deficiency explanations and/or comments on this list or on the comment
sheet(s). Place a check beside all other items you observed or verified at the laboratory.

1 Organization and management
(See General Operations Checklist.)
2 Quality system, audit and review
___ 2.1 The laboratory shall have the following documents available for reference:

NIST Handbook 150, NVLAP Procedures and General Requirements;
NIST Handbook 150-18, NVLAP Fasteners and Metals;

Fastener Quality Act, Public Law 101-592, 1990;

National Technology Transfer and Advancement Act, Public Law 104-
113, 1995; and

2.1.5 Procedures for Implementation of the Fastener Quality Act, Title 15,
Part 280 of the U.S. Code of Federal Regulations (CFR).

NNNN

BoRS

| |||

2.2 The laboratory’s quality documentation contains procedures or instructions
describing the following:

2.2.1 training of staff and quality assurance of analyst performance;
2.2.2 sample custody and handling procedures;

2.2.3. equipment maintenance and calibration; and

2.2.4 recordkeeping and generation of reports.

2.3 The laboratory shall conduct an internal audit of the laboratory not less than
annually to verify that the operations of the laboratory are in compliance with its quality
manual and this program.

3 Personnel

3.1 The laboratory shall ensure that staff members are aware of the extent of their
area of responsibility.

3.2 The laboratory shall maintain documentation for each staff member which
contains:

NIST Handbook 150-18 C3 August 1996


NVLAP LAB CODE:

(vi)

(vii)
(viii)

(ix)

(xi)

(xii)

(xifi)

(xiv)

(xv)
a)
b)

(xvi)

(xvii)

(xviii)

(xix)

(xx)

(xxi)

identification of the laboratory’s approved signatories (list here or in the
comments section):

the laboratory’s procedures for achieving traceability of measurements;

the laboratory’s scope of calibrations and/or tests;

written procedures for ensuring that the laboratory reviews all new work to
ensure that it has the appropriate facilities and resources before commencing
such work;

reference to the calibration, verification and/or test procedures used;

procedures for handling calibration and test items;

reference to the major equipment and reference measurement standards
used;

reference to procedures for calibration, verification and maintenance of
equipment;

reference to verification practices including interlaboratory comparisons,
proficiency testing programs, use of reference materials and internal quality
control schemes [see also (b)(2)(x), (c)(6)(ii), (g)(3)];

procedures to be followed for feedback and corrective action whenever:
testing discrepancies are detected, or
departures from documented policies and procedures occur;

the laboratory management policies for departures from documented policies
and procedures or from standard specifications;

procedures for dealing with complaints [see also (n)];

procedures for protecting confidentiality and proprietary rights [see also
(b)(2)(ix)];

procedures for audit and review;
a description of the laboratory’s policy regarding the use of the NVLAP logo;

a statement of the laboratory's policy for establishing and changing
calibration intervals for equipment it controls; and

NIST Handbook 150-18 BO August 1996


NVLAP LAB CODE:

(7)

(8)

—— fi)

(ii)

The laboratory shall ensure that, where clients require transmission of
calibration or test results by telephone, telex, facsimile or other electronic or
electromagnetic means, staff will follow documented procedures that ensure
that the NVLAP requirements are met and that confidentiality is preserved.

Whenever a laboratory accredited by NVLAP issues a calibration or test
report which contains data covered by the accreditation and also data not
covered by the accreditation, it must clearly identify in its records, and in the
report to the client, specifically which calibration or test method(s), or
portion of a calibration or test method(s), was not covered by the
accreditation. The laboratory must also inform the client, before the fact,
when calibrations or tests requested are not covered by the accreditation.

NVLAP policy regarding calibration and test reports issued by an accredited
laboratory, which reference the laboratory’s accredited status, requires that
any calibration or test report containing data from calibrations or tests which
are not covered by the accreditation include:

a statement at the beginning of the report prominently indicating, "This
report contains data which are not covered by the NVLAP accreditation";
and

a clear indication of which data are not covered by the accreditation.
The laboratory must not misrepresent its accreditation. When a client

requires or requests accredited services and any of the requested services
are not covered by the accreditation, the client must be so advised.

NIST Handbook 150-18 B-24 August 1996


TABLE OF CONTENTS

PREFACE 2.1... eee ee iii
ACKNOWLEDGMENTS .............. 20-2000 00 e eee eee iv
SUMMARY ... 1... ee vi
Sec, 285.1 Purpose... 6 eee 1
Sec. 285.2 Organization of procedures... 2... ee 1
Sec. 285.3 Description of Fasteners and Metals program ............. 00.000 eee eee 1
Sec. 285.4 References ©... 0... eee 1
Sec, 285.5 Definitions .. 2.6... 0... 0. eee 2
Sec. 285.6 NVLAP documentation ... 2.2... 22 ee 2
Sec, 285.22 Assessing and evaluating a laboratory ..........-2-... 000-0000 ee 3
Sec. 285.23 Granting and renewing accreditation ©... 2.1... eee eee 5
Sec. 285.33 Criteria for accreditation 2.2... 0.0.0.0. 0. eee eee 5
(c) Quality system, audit and review ©... 0.20.0... 000 cee eee ee 5
(d) Personnel : . : : .. 6
(e) Accommodation and environment ...........0.00 000000 cee ee eee eee 6
(f) | Equipment and reference materials 2.2... 2.0... ee ee 6
(g) | Measurement traceability and calibration . : : -. 6
(h) Calibration and test methods ... 2.2... 00... ee 7
(i) Handling of calibration and test items 8
Gj) Records 2... eee : : : .. 8
(k) Certificates and reports 2.0... 2. eee 8
(1) Subcontracting of calibration or testing ........... 0... .00 0000002 e eee 9
(m) Outside support services and supplies : : : - 10
(mn) Complaints... 0... .. 0.0.0 cee ee 10
APPENDICES
SAMPLE ACCREDITATION DOCUMENTS . : : . Al
GENERAL OPERATIONS CHECKLIST ...............- : : : . Bl
SPECIFIC OPERATIONS CHECKLIST ........ 00... c eee eee ee C1
ON-SITE ASSESSMENT - TEST METHOD REVIEW ...............-..2...- D-1
MAJOR AREAS OF TESTING .. 10.0.0... 0c cc ee ee E-1


NVLAP LAB CODE:

(4)

(5)

(6)

(7)

(i)

(ii)

(iii)

(iv)

Where it is necessary to employ methods that have not been established as
standard, these shall be subject to agreement with the client, be fully
documented and validated, and be available to the client and other recipients
of the relevant reports [see also (k)(2)(x)].

Where sampling is carried out as part of the test method, the laboratory shall
use documented procedures and appropriate statistical techniques to select
samples [see also (k)(2)(ix)].

Calculations and data transfers shall be subject to appropriate checks.

Where computers or automated equipment are used for the capture,
processing, manipulation, recording, reporting, storage or retrieval of
calibration or test data, the laboratory shall have written procedures which
ensure that:

the NVLAP requirements are complied with;

computer software, computers or automated equipment is documented and
adequate for use;

procedures are established and implemented for protecting the integrity of
data; such procedures shall include, but not be limited to, integrity of data
entry or capture, data storage, data transmission and data processing;

computer and automated equipment is maintained to ensure proper
functioning and provided with the environmental and operating conditions
necessary to maintain the integrity of calibration and test data [see also
(FV);

NIST Handbook 150-18 B-17 August 1996


NVLAP LAB CODE:

GENERAL OPERATIONS CHECKLIST

Instructions to the Assessor: This checklist addresses general accreditation criteria prescribed
in applicable sections of NIST Handbook 150, NVLAP Procedures and General Requirements.

This checklist follows and is numbered to correspond to the NVLAP Procedures and General
Requirements, Subsection 285.33. The numbers in square brackets identify related checklist
items. A small black triangle appears in the left-hand margin of selected lines of text
throughout this checklist; the marked text applies only to the Calibration Laboratory
Accreditation Program (LAP).
Place an "X" beside each checklist item which represents a deficiency. Place a "C" beside
each item on which you are commenting for other reasons. Record the item number and your
written deficiency explanations and/or comments in this list or on the attached comment
sheets. Place a check beside all other items you observed or verified at the laboratory.
SEC. 285.33 CRITERIA FOR ACCREDITATION
{b) Organization and management

(1) The laboratory shall be:
fi) legally identifiable;

Legal name of laboratory ownership:

(ii) organized and shall operate in such a way that its permanent, temporary and
mobile facilities meet the NVLAP requirements [see also (b)(2)(i), (c)(2)(ii)];

(iii) properly identified on the NVLAP Application.

{2) The laboratory shall:

(i) have managerial staff with the authority and resources needed to discharge
their duties [see also (b)(1){ii), (c)(2)(ii}];

(ii) have policies to ensure that its personnel are free from any commercial,
financial and other pressures which might adversely affect the quality of their
work;

(iii) be organized in such a way that confidence in its independence of judgment
and integrity is maintained at all times;

NIST Handbook 150-18 B-3 August 1996


NVLAP LAB CODE:

(3)

Records on the relevant qualifications, training, skills and experience of the
technical personnel shall be maintained by the laboratory.

(e) Accommodation (facilities) and environment [see also (i)(3)]

(1)

(2)

Laboratory accommodation, calibration and test areas, energy sources,
lighting, heating and ventilation shall be such as to facilitate proper
performance of calibrations or tests.

NOTE: Laboratory design will be, to the maximum extent practical, in
accordance with the guidelines found in the NCSL Recommended Practice
#7, Laboratory Design, July 25, 1993.

The environment in which these activities are undertaken shall not invalidate
the results or adversely affect the required accuracy of measurement.
Particular care shall be taken when such activities are undertaken at sites
other than the permanent laboratory premises.

NOTE: It is expected that environments which do not meet generally
accepted norms, such as those found in NCSL Recommended Practice #7,
yet which exhibit the stability required to apply necessary correction factors,
will be specified by the laboratory for the purpose of assessment of
compliance with its own procedures to achieve its stated uncertainties.

NIST Handbook 150-18 B-9 August 1996


NVLAP LAB CODE:

—— ii)

(iii)

(iv)

{v)

(vi)

(2)

(i)

(ii)

(iii)

(iv)

(v)

have the elements of the quality system documented;

ensure that the quality documentation is available for use by the laboratory
personnel;

define and document its policies and objectives for, and its commitment to,
good laboratory practice and quality of calibration or testing services;

have the laboratory management which ensures that these policies and
objectives are documented in a quality manual and communicated to,

understood, and implemented by all laboratory personnel concerned;

ensure that the quality manual is maintained current under the responsibility
of the quality manager [see also (c)(2)(iv)].

Date of quality manual:

Date of latest update:

The quality manual, and related quality documentation, shall state the
laboratory's policies and operational procedures established in order to meet
the NVLAP requirements. The quality manual and related quality
documentation shall contain:

a quality policy statement, including objectives and commitments, by top
management;

the organization and management structure of the laboratory, its place in any
parent organization and relevant organizational charts;

the relations between management, technical operations, support services
and the quality system;

procedures for control and maintenance of documentation [see also (c){1)(vi),
GMT;

job descriptions of key staff and reference to the job descriptions of other
staff;

NIST Handbook 150-18 B-S August 1996


NVLAP LAB CODE:

(v)

(8)

it establishes and implements appropriate procedures for the maintenance of
security of data including the prevention of unauthorized access to, and the
unauthorized amendment of, computer records.

Documented procedures shall exist for the purchase, reception and storage
of consumable materials used for the technical operations of the laboratory
[see also (m)(2)].

(i) Handling of calibration and test items

(1)

(2)

The laboratory shall have a documented system for uniquely identifying the
items to be calibrated or tested, to ensure that there can be no confusion
regarding the identity of such items at any time [see also (k)(2){v)].

Upon receipt, the condition of the calibration or test item, including any
abnormalities or departures from standard condition as prescribed in the
relevant calibration or test method, shall be recorded. Where there is any
doubt as to the item’s suitability for calibration or test, where the item does
not conform to the description provided, or where the calibration or test
required is not fully specified, the laboratory shall consult the client for
further instruction before proceeding. The laboratory shall establish whether
the item has received all necessary preparation, or whether the client
requires preparation to be undertaken or arranged by the laboratory.

NIST Handbook 150-18 B-18 August 1996


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A-3

NIST Handbook 150-18


NVLAP LAB CODE:

ON-SITE ASSESSMENT -
TEST METHOD REVIEW COMMENTS AND DEFICIENCIES

Instructions to the Assessor: Use this sheet to document comments and deficiencies. For
each, identify the appropriate item number. Identify comments with a "C" and deficiencies
with an "X." If additional space is needed, make copies of this page (or use additional blank
sheets).

Test Method
(number, name, Comments and/or Deficiencies as Noted on the On-Site Assessment -
or designation) Test Method Review Summary

NIST Handbook 150-18 D-5 August 1996


test and reporting the results. The test shall be
conducted in accordance with a specific test
method using the laboratory’s normal operating
procedures. Proficiency testing shall not be
contracted out to another laboratory. Any
special NVLAP instructions shall also be
followed. The special instructions are designed
to ensure uniformity in procedures among
participants. Completed data sheets shall be
returned to NVLAP or its designated contractor
for analysis by a specified date. Failure to
return the proficiency testing data sheets by the
deadline date will result in penalties which may
include failing that round.

(3) Proficiency testing may involve materials
or artifacts that must be returned to NVLAP for
use by other participants. These materials shall
be protected from damage both in the laboratory
and during shipment back to NVLAP, or its
designated contractor. Examples of such
materials and artifacts are: filters, grids,
photographs and data sheets. These materials
may be used to determine testing performance
for specific subparts of the test method. Unless
otherwise noted, laboratories should keep
proficiency testing materials for use as in-house
- instructional material.

(4) On occasion, the on-site assessor hand
carries proficiency test samples to the
laboratory. These proficiency test samples, like
all others received by the laboratory, are to be
listed or entered into the normal sample tracking
and identification system for control and data
recording. In these cases, the samples may be
returned to the on-site assessor rather than
stored at the laboratory. Additionally, in some
cases, the laboratory may be instructed to send
the samples back to the proficiency testing
contractor, or to a destination specified by
NVLAP or the proficiency testing contractor.

(5) The results of the proficiency testing
program will be reported to the participants and.
in appropriate documents and reports. The
identity and performance of individual
laboratories will remain confidential. The
results of proficiency testing will be made
available to on-site assessors for use during
laboratory visits. Any problems indicated by
proficiency testing will be discussed with
appropriate laboratory personnel, who will then
be responsible for developing and implementing
plans for resolving the problems. Accreditation

decisions will be based on satisfactory resolution
of proficiency testing deficiencies.

(6) Participation in proficiency testing is
required for laboratories applying for
accreditation for test methods under Rockwell
hardness of fasteners (externally threaded), axial
tensile strength of full-size threaded fasteners,
wedge tensile strength of full-size threaded
fasteners, and chemistry. Proficiency testing
will be conducted twice annually for each of
these areas of testing.

NVLAP may expand its requirements for
proficiency testing to include other test methods
in the major areas of testing.

A proficiency test will use statistical and
graphical techniques to examine the
performance of each laboratory based on the
results obtained on paired test samples. After
analyzing the results for each individual sample
and then plotting each laboratory’s results on a
Youden two-sample plot, a simultaneous
analysis is performed. In this last step, a 95%
control ellipse is drawn such that 95% of the
time, a randomly selected laboratory is included
in the ellipse.

If a laboratory exceeds the critical limit on
either of the two samples, it will fail the
simultaneous analysis. Also, a laboratory that
does not exceed the critical value for an
individual sample can still fall outside the
control ellipse if its results are inconsistent.
This critical value, which sets the lower and
upper limits for extreme data, will vary
depending upon the number of participants in a
given proficiency test.

Submitted results which are incomplete or which
fall outside the 99% confidence level will be
considered as failing.

(7) If an accredited laboratory fails a
proficiency test, it must do the following in
order to maintain its accreditation:

@ Provide, within 30 days of
notification of failure, detailed, written
documentation to NVLAP, that includes an
analysis of why the laboratory failed each
part of the test, and what corrective
actions it has taken (analyst training,
revised procedures, quality assurance

NIST Handbook 150-18

August 1996


NVLAP LAB CODE:

(7) Reference materials shall, where possible, be traceable to national or
international standards of measurement, or to national or international
standard reference materials.

(h) Calibration and test methods

(1) The laboratory shall have documented instructions on the use and operation
of all relevant equipment, on the handling and preparation of items and for
calibration and/or testing, where the absence of such instructions could
jeopardize the calibrations or tests. All instructions, standards, manuals and
reference data relevant to the work of the laboratory shall be maintained
up-to-date and be readily available to the staff.

NIST Handbook 150-18 B-15 August 1996


NVLAP LAB CODE:

—— iii)

(iii)

tiv)

(vi)
(vii)

(viii)

(ix)

(x)

the manufacturer’s name, type identification, and serial number or other
unique identification;

date received and date placed in service;

NOTE: For initial accreditation, the date received and the date placed in
service are not considered mandatory requirements for inclusion in laboratory
records, although this is encouraged as good laboratory practice.

current location, where appropriate;

condition when received (e.g., new, used, reconditioned);

copy of the manufacturer's instructions, where available;

dates and results of calibrations and/or verifications and date of next
calibration and/or verification;

details of maintenance carried out to date and planned for the future;
history of any damage, malfunction, modification or repair;

measured value observed for each parameter found to be out of tolerance
during calibration/verification.

(g) Measurement traceability and calibration

(1)

All measuring and testing equipment having an effect on the accuracy or
validity of calibrations or tests shall be calibrated and/or verified before being
put into service. The laboratory shall have an established program for the
calibration and verification of its measuring and test equipment. The
program will ensure the recall or removal from service of any standard or
equipment which has exceeded its calibration interval or is otherwise judged
to be unreliable.

NIST Handbook 150-18 B-12 August 1996


Sec. 285.1 Purpose

The purpose of this handbook is to set out procedures
and technical requirements for accreditation by
NVLAP of laboratories which perform testing on
fasteners and metals using standards and
specifications which are published by a consensus
standards organization or by a government agency in
the areas of chemical analysis, dimensional
inspection, mechanical and physical testing and
inspection, metallography, and nondestructive
inspection.

This handbook complements and supplements the
NVLAP programmatic procedures and general
requirements found in NIST Handbook 150 and the
superseding requirements found in the Fastener
Quality Act, PL 101-592, as amended by the National
Technology Transfer and Advancement Act, PL 104-
113, and its implementing regulations as described in
Title 15, Part 280 of the U.S. Code of Federal
Regulations. The interpretive comments and
additional requirements contained in this handbook
make the general NVLAP criteria specifically
applicable to the Fasteners and Metals program.
Specific circumstances under which departures from
the NVLAP general procedures are allowable within
the scope of the Fasteners and Metals program are
also addressed in this handbook.

Sec. 285.2 Organization of procedures

(a) The handbook is organized to cross-reference
with NIST Handbook 150, NVLAP Procedures and
General Requirements. The format and subject
headings used in this handbook, including the
checklist found in Appendix B, are consistent with
Handbook 150.

(b) The handbook contains five appendices:

(1) Appendix A provides examples of a
Certificate of Accreditation and a Scope of
Accreditation for the Fasteners and Metals
program;

(2) Appendix B provides the General
Operations Checklist which NVLAP assessors
use during an on-site assessment to evaluate a
laboratory’s ability to conduct testing in general;

(3) Appendix C provides the Specific
Operations Checklist which NVLAP assessors
use during an on-site assessment of a laboratory
that performs testing on fasteners and metals;

(4) Appendix D provides the sheets that the
assessor completes in conducting a review of the
test methods; and

(5) Appendix E lists the testing areas, groups
and subgroups for the Fasteners and Metals
accreditation program.

Sec. 285.3 Description of Fasteners and Metals
program

The Fastener Quality Act (FQA), Public Law 101-
592, was signed by President Bush on November 16,
1990. The Act protects the public safety by: (1)
requiring that certain fasteners sold in commerce
conform to the specifications to which they are
represented to be manufactured, (2) providing for
accreditation of laboratories engaged in fastener
testing, and (3) requiring inspection, testing and
certification in accordance with standardized methods.

The Act requires the Secretary of Commerce, acting
through the Director of NIST, to establish a
laboratory accreditation program for fastener testing
laboratories under the procedures of the National
Voluntary Laboratory Accreditation Program
(NVLAP). The accreditation program includes test
methods which are required by fastener specifications
or standards covered by the Act. Since fastener
testing involves a wide range of expertise,
accreditation will be offered in the areas of
mechanical and physical testing and inspection,
metallography, nondestructive inspection,
dimensional inspection, and chemical analysis.

On March 7, 1996, President Clinton signed the
National Technology Transfer and Advancement Act
of 1995, Public Law 104-113, which amended the
Fastener Quality Act to further clarify and define the
requirements of the original Act.

Sec. 285.4 References

References and sources for the Fasteners and Metals
program follow:

(a) NIST Handbook 150, NVLAP Procedures and
General Requirements (March 1994); available from:

NIST/NVLAP
Building 820, Room 282
Gaithersburg, MD 20899

NIST Handbook 150-18

August 1996


SUMMARY

Any laboratory (including commercial, manufacturer, university, or federal, state, or local government
laboratory) that performs consensus test methods on fasteners and metals may apply for NVLAP
accreditation. Accreditation will be granted to a laboratory that satisfactorily fulfills the conditions for
accreditation defined in NIST Handbook 150, NVLAP Procedures and General Requirements, the
superseding requirements defined in PL 101-592, the Fastener Quality Act, as amended by the National
Technology Transfer and Advancement Act, PL 104-113, and the implementing regulations described in
Title 15, Part 280 of the U.S. Code of Federal Regulations. These conditions include satisfactory
performance in selected proficiency testing as required, and fulfilling the on-site assessment requirements,
including resolution of any identified deficiencies. The names of NVLAP-accredited laboratories are
published in the NVLAP annual directory and other media to which information is regularly provided.
The names of NVLAP-accredited fastener testing laboratories will also be published in the NIST list of
all testing laboratories accredited under the requirements of the Fastener Quality Act.

Test methods covered: Standards and specifications which are published by a consensus standards
organization or by a government agency in the areas of chemical analysis, dimensional inspection,
mechanical and physical testing and inspection, metallography, and nondestructive inspection.

Period of accreditation: One year, renewable annually.

On-site assessment: Visit by a technical expert to determine compliance with the NVLAP criteria before
initial accreditation and every two years thereafter. Additional monitoring visits as required.

Assessors: Technical experts with experience in the appropriate field of testing.

Proficiency testing: Each laboratory is required to test and analyze proficiency testing sample
material(s). The completed test data report is sent to NVLAP, or as directed to the proficiency
testing contractor. A summary of results is sent to the participants.

Granting accreditation: Based upon satisfactory on-site assessment and resolution of deficiencies,
proficiency testing, and technical evaluation of applicable laboratory information. A Certificate and

Scope of Accreditation are issued to the laboratory.

Fees: Payments are required as listed on the NVLAP fee schedule.

vi


®
National Institute National Voluntary
of Standards and Technology Laboratory Accreditation Program
> 4

isonec cue 21990 ScQne of Accreditation

Page 1 of 1
FASTENERS AND METALS NVLAP LAB CODE 100000-0
LABORATORY, INC.
1 Main Street
Anytown, USA 00000
John Doe Phone: 301-555-1212
NVLAP Code Designation Short Title
MECHANICAL AND PHYSICAL TESTING AND INSPECTION
Corrosion
Humidity Testing of Fasteners
| 21/KXXX MIL-STD-753C Corrosion—Resistant Steel Parts
METALLOGRAPHY
Determination of Grain Size of Fasteners
21/XXXX SAE 3418 Grain Size Determination of Steels
CHEMICAL ANALYSIS
Solution Chemical Analysis
21/KXXX ASTM E1473-92 Chemical Analysis of Nickel, Cobalt and High-

Temperature Alloys

December 31, 19XX _— KSE—

Fffective through Fron the National Institute off Standards and Technology

NVLAP-01S (11-95)

NIST Handbook 150-18 A-4 August 1996


management, and quality system in addition to its
testing competency.

The General Operations Checklist, presented in
Appendix B, is numbered to correspond to the
requirements in NIST Handbook 150. The comment
sheets are used by the assessor to explain findings
and deficiencies noted on the checklist, as well as to
make comments on aspects of the laboratory’s
performance other than deficiencies.

(b) The Specific Operations Checklist contains
statements or questions that are specific to the
Fasteners and Metals program. This checklist is
contained in Appendix C, along with a comment
sheet(s) similar to that used with the General
Operations Checklist.

Sec. 285.22 Assessing and evaluating a laboratory
(a) On-Site Assessment

(1) The NVLAP assessor may request manuals
and/or documented procedures in advance of the
on-site assessment to reduce time at the
laboratory. Documents supplied in advance will
be returned. The laboratory should be prepared

* for conducting test demonstrations, have
equipment in good working order, and be ready
for examination according to the requirements
identified in this handbook, NIST Handbook
150, and the laboratory’s quality manual. The
assessor will need time and work space to
complete assessment documentation during the
visit.

(2) In addition to the checklists, to help assure
the completeness, objectivity, and uniformity of
the on-site assessment, the assessor uses the On-
Site Assessment—Test Method Review sheets
(Appendix D) in reviewing the laboratory’s
ability to perform the test methods. The test
method review ranges from observing tests to
having laboratory staff describe the test
procedures. The assessor notes the depth into
which each part of the test method was
reviewed and records the results of the review
on the On-Site Assessment—Test Method
Review Summary (p. D-4).

(3) An assessor performs the following
activities during a typical on-site assessment:

(i) Conducts an entry briefing with the
laboratory manager to explain the purpose

of the on-site visit and to discuss the
schedule for the day(s). At the discretion
of the laboratory manager, other staff may
attend the briefing.

Reviews laboratory quality manual
(if not previously requested and supplied)
and records. At least one laboratory staff
member must be available to answer
questions; however, the assessor may wish
to review the documents alone. The
assessor does not usually ask to take any
laboratory documents with him/her and
documents previously supplied will be
returned.

(iii) Physically examines equipment and
facilities and observes the demonstration of
selected procedures by appropriate
personnel assigned to conduct the tests,
and interviews those personnel. The
demonstrations requested may be selective
or all-inclusive, and must include sample
test material(s), preparation of devices,
establishment of test conditions and the
setup/use of major equipment. The
assessor may provide proficiency test
samples and request a_ specific
demonstration.

(iv) Completes an On-Site Assessment
Report, which contains the minimum
requirements prescribed in NIST
Handbook 150, as well as copies of the
completed checklists. At the exit briefing,
the report is signed by the assessor and the
laboratory’s Authorized Representative to
acknowledge the discussion, but does not
necessarily indicate agreement;
challenge(s) may be made through
NVLAP. All observations made by the
NVLAP assessor are held in the strictest
confidence.

(b) Proficiency Testing

(1) The proficiency testing program may be
conducted by NVLAP or by a NVLAP-
approved contractor. Proficiency testing
materials are chosen to test the laboratory’s
ability to follow a method and to achieve the
proper accuracy and precision.

(2) Laboratories will be sent test materials,
data sheets, and instructions for performing the

NIST Handbook 150-18

August 1996


v

NVLAP LAB CODE:

(xxii)

(3)

(4)

(5)

a statement of the laboratory’s policy concerning the technique(s) to be used
for determining measurement uncertainty and calibration/verification
adequacy.

The laboratory shall arrange for audits of its activities at appropriate intervals
to verify that its operations continue to comply with the requirements of the
quality system. Such audits shall be carried out by trained and qualified staff
who are, wherever possible, independent of the activity to be audited.
Where the audit findings cast doubt on the correctness or validity of the
laboratory's calibration or test results, the laboratory shall take immediate
corrective action and shall immediately notify, in writing, any client whose
work may have been affected.

The audits shall be objective and be conducted internally or on contract. The
audits shall include both general criteria (documents, records and policies)
and technical compliance (test methods and practices and calibration
procedures). :

The quality system adopted to satisfy the NVLAP requirements shall be
reviewed at least once a year by the management to ensure its continuing
suitability and effectiveness and to introduce any necessary changes or
improvements.

All audit and review findings and any corrective actions that arise from them
shall be documented. The person responsible for quality shall ensure that
these actions are discharged within the agreed timescale.

NIST Handbook 150-18 B-7 August 1996


NIST HANDBOOK 150-18

National
Voluntary
Laboratory
Accreditation
Program

Fasteners
and
Metals

David F. Alderman

August 1996

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Michael Kantor, Secretary

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Mary L. Good, Under Secretary for Technology

National Institute of Standards and Technology
Arati Prabhakar, Director


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NVLAP LAB CODE:

(vii)

(viii)

(ix)

(x)

(xi)

(xii)

Adequacy of calibration system: The supplier shall establish and maintain
documented procedures to evaluate the adequacy of the calibration system
and to ensure compliance with these requirements.

Calibration sources: M & TE requiring calibration shall be calibrated or
verified by laboratories that comply with sections 285.33(b) through (n).

Records: These requirements shall be supported by records documenting
that established schedules and procedures are followed to maintain the
adequacy of allM & TE. The records for M & TE requiring calibration shall
include an individual record of calibration or verification, or other means of
control, providing a description or identification of the item, calibration
interval, date calibrated, identification of the calibration source, calibration
results (data and/or condition status) and calibration action taken (adjusted,
repaired, new value assigned, derated, etc.).

Calibration status: M & TE shall be labeled to indicate calibration or
verification status. The label shall identify specific date calibrated (day,
month, year, Julian date, or equivalent) and the specific calibration due date
or usage equivalent. Items not calibrated to their full capability or which
have other limitations of use, shall be labeled or otherwise identified as to
the limitations. When it is impractical to apply a label directly to an item, the
label may be affixed to the instrument container or some other suitable
means may be used to reflect calibration status. Tamper-resistant seals are
affixed to operator accessible controls or adjustments which if moved will
invalidate the calibration. The quality system shall provide instructions for
the disposition of equipment with broken tamper-resistant seals.

Control of subcontractor calibration: The supplier is responsible for assuring
that the subcontractor’s calibration system conforms to section 285.33 (I) to
the degree necessary to assure compliance with contractual requirements.
NVLAP accreditation of the subcontractor’s laboratory can serve as the basis
for compliance with this requirement.

Storage and handling: M & TE shall be handled, stored, and transported in a
manner which shall not adversely affect the calibration or condition of the
equipment.

NIST Handbook 150-18 B-30 August 1996


(d)

~ 3) Analysts,

shall not be postponed during periods of heavy
work loads.

(5) The laboratory shall maintain and
summarize all of the quality assurance activities
on a frequent enough basis to detect problems.

(6) Laboratories seeking accreditation under
the Fasteners and Metals program shall have
available a copy of all references listed under
Sec. 285.4 of this handbook.

Personnel

(1) Employees shall be aware of the extent of
their area of responsibility. This information
shall be available in the required job
descriptions found in the quality documentation
and individual files.

(2) The laboratory shall have a written
description of its training program including its
criteria for successful completion. The
laboratory shall establish and document
performance criteria to determine when a new
analyst is qualified for working independently.

technicians, and technical
supervisors shall participate in an appropriate
form of continuing education, such as formal
coursework, in-house education, and scientific
or technical meetings, and have access to
journals that describe advances in the field of
testing.

(4) Analyst proficiency is important to
providing reliable data. All analysts shall be
tested routinely to evaluate their performance.
Test results shall be recorded in the personnel
folder or equivalent of each staff member, and
be available during NVLAP on-site assessments.
Testing shall be frequent enough to ensure
quality analyses. Problems shall be discussed
with the analyst, and corrected according to
documented procedures. Subsequent quality
assurance tests shall determine whether the
problem has been corrected. The laboratory
shall ensure the quality of analyses while the
problem is being corrected. All corrective
actions shall be documented in quality assurance
summaries, periodic laboratory audits, and
individual analyst’s files.

(5) The laboratory shall be organized so that
staff members are not subjected to undue

©

0)

(g)

pressure or inducement that might influence
their judgment or results of their work. The
laboratory shall be able to demonstrate that the
sample work load required for each analyst is
consistent with accurate and precise analytical
measurement.

(6) The laboratory will be responsible for
demonstrating its competence to analyze samples
following the practice outlined in its quality
documentation. Any staff member involved in
the analysis of samples will be responsible for
demonstrating their competence as required
during an on-site assessment.

Accommodation and environment
(See NIST Handbook 150.)
Equipment and reference materials

(1) All equipment shall be properly maintained
to ensure protection from corrosion and other
causes of deterioration. Instructions for proper
maintenance of equipment which requires
periodic maintenance must be available. Any
equipment or component thereof which has been
subjected to overloading or mishandling, gives
suspect results, or has been shown by
calibration or otherwise to be defective, must be
taken out of service and clearly labeled until it
has been repaired. When placed back in
service, this equipment must be shown by test
or calibration to be performing its functions
satisfactorily.

(2) Where available, the laboratory shall have
reference materials and any associated
certificates for evaluation of personnel and
calibration of equipment.

(3) The laboratory shall maintain procedures
for ensuring that automated test systems
function properly and are used properly.

Measurement traceability and calibration

(1) The laboratory’s calibrations may be
performed by properly trained staff using
calibrated standards traceable to NIST or by
using a NVLAP-accredited calibration
laboratory. All calibrations and
characterizations must be done against reference
standards that are traceable to national standards
maintained by NIST or by a foreign national

NIST Handbook 150-18

August 1996


activities, etc.) to resolve its analytical
problems so as to avoid similar errors in
the future. Documented evidence that the
corrective actions have been effectively
implemented is required.

(ii) Participate successfully in the next
round of proficiency testing.

(8) If a laboratory fails the same type of
proficiency testing twice in succession or
generally exhibits an erratic pattern in testing,
NVLAP will review all current and previous
proficiency testing results and advise the
laboratory on what actions must be taken to
correct the deficiency. Failure to correct the
deficiency may result in suspension of
accreditation. In some cases, in order to regain
accreditation, the laboratory shall undergo a
complete on-site assessment to determine the
cause of the deficiencies, and to determine that
effective corrective actions have been
implemented. The laboratory shall provide
NVLAP with documentation within 30 days of
the assessment, adequately demonstrating that
the deficiencies noted by the assessor have been
satisfactorily resolved. Failure to perform fully

- satisfactorily in the on-site assessment will result
in accreditation remaining suspended.

(9) The full cost of any on-site assessment
shall be paid in advance by the laboratory.
NVLAP staff will make every effort to expedite
these extraordinary assessments to give a
laboratory every reasonable opportunity to
demonstrate competence to perform the test
method and regain accreditation.

(10) Failure to participate in a round of
proficiency testing will result in immediate
suspension of accreditation, and the laboratory
shall successfully participate in the next
regularly scheduled round in order to have its
accreditation reinstated.

Sec, 285,23 Granting and renewing accreditation

Laboratories granted NVLAP accreditation are
provided with two documents: a Certificate of
Accreditation and a Scope of Accreditation. Samples
of these accreditation documents for the Fasteners
and Metals program are shown in Appendix A, Note
that the certificate states that the criteria encompass
the requirements of ISO/IEC Guide 25 and the

relevant requirements of ISO 9002 (ANSI/ASQC
Q92-1987).

Sec. 285.33 Criteria for accreditation

(©) Quality system, audit and review

(1) The laboratory shall define and document
quality objectives for obtaining accurate and
precise analytical data. These objectives shall
be the benchmark by which the laboratory
management assesses overall and individual
performance,

(2) Under its quality system, the laboratory
shall develop and implement procedures
covering all the technical requirements of this
handbook. A laboratory analyst shall be able to
obtain enough information from the laboratory’s
quality documentation to perform analyses in the
absence of the laboratory manager. Periodic
reviews of the quality system shall reflect
adherence to NVLAP requirements and the
laboratory’s quality objectives. These reviews
shall also reflect positive aspects of the quality
system as well as deficiencies.

(3) The quality manual shall describe the
laboratory’s staff, facilities and equipment, test
procedures, calibration procedures, sample
custody and handling procedures and test report
format and procedures. The quality system
documentation shall contain:

- specific records (or reference to records)
of calibration tests, samples received and
their locations, and test reports that have
been issued;

- schedules for routine quality assurance
checks such as calibration;

- filled-in examples of all standardized
forms used in the laboratory; and

- procedures for storage and retrieval of
records.

(4) The laboratory’s quality assurance checks
shall be performed routinely, covering all time
periods, sample types, instruments, tasks and
personnel. The selection of samples for quality
assurance checks shall be semirandom and,
when possible, the specific checks on personnel
performance shall be executed without their
prior knowledge. A disproportionate number of
analyses shall not be performed prior to internal
or external audits. Quality assurance activities

NIST Handbook 150-18

August 1996


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NIST Handbook 150-18


NVLAP LAB CODE:

(v)

include at the beginning of the report the name, address, and contact person
of the subcontracted laboratory(ies), and one of the following statements, as
appropriate:

if NVLAP-accredited

"This report contains data which were produced by a subcontracted
laboratory ACCREDITED (NVLAP LAB CODE) for the calibration or test
methods performed"

if not NVLAP-accredited

“This report contains data which were produced by a subcontracted
laboratory NOT ACCREDITED for the calibration or test methods performed."

The requirements of this section do not supersede any regulation, law,
contract specification, or other related conditions which require NVLAP
accreditation.

(m) Outside support services and supplies

(1)

Where the laboratory procures outside services and supplies in support of
calibrations or tests, the laboratory shall use only those outside support
services and supplies that are of adequate quality to sustain confidence in
the laboratory’s calibrations or tests.

NIST Handbook 150-18 B-26 August 1996


NVLAP LAB CODE:

(3) Where traceability to national standards of measurement is not applicable,
the laboratory shall provide satisfactory evidence of correlation of results, for
example by participation in a suitable program of interlaboratory comparisons
or proficiency testing [see also (b)(2)(x), (c)(2)}(xiv), (c)(6){ii)].

NOTE: Traceability requirements may also be satisfied by:

(i) internationally accepted standards in the field concerned;
(ii) suitable reference materials;

(iii) ratio or reciprocity measurements; or

{iv) mutual consent standards which are clearly specified and mutually
agreed upon by all parties concerned.

(4) Reference standards of measurement held by the laboratory shall be used for
calibration only and for no other purpose, unless it can be demonstrated that
their performance as reference standards has not been invalidated.

(5) Reference standards of measurement shall be calibrated by a body that can
provide traceability to a national standard of measurement. There shall be a
program of calibration and verification for reference standards.

(6) Where relevant, reference standards and measuring and testing equipment
shall be subjected to in-service checks between calibrations and verifications.

NIST Handbook 150-18 B-14 August 1996


NVLAP LAB CODE:

GENERAL OPERATIONS CHECKLIST - COMMENTS AND DEFICIENCIES

Instructions to the Assessor: Use this sheet to document comments and deficiencies. For
each, identify the appropriate item number from the checklist. Identify comments with a
"C" and deficiencies with an "X." If additional space is needed, make copies of this page
(or use additional blank sheets).

item No. Comments and/or Deficiencies

NIST Handbook 150-18 B-31 August 1996


NVLAP LAB CODE:

(2) The overall program of calibration and/or verification and validation of
equipment shall be designed and operated so as to ensure that, wherever
applicable, measurements made by the laboratory are traceable to national
standards of measurement where available. Calibration certificates shall,
wherever applicable, indicate the traceability to national standards of
Measurement and shall provide the measurement results and associated
uncertainty of measurement and/or a statement of compliance with an
identified metrological specification.

NOTE: Traceability to national standards includes traceability to standards
maintained or defined at national laboratories in foreign countries where
applicable. In these cases, traceability is achieved via international
standards. This includes intrinsic standards of measurement where available.

Where applicable, the methodology of the Guide to the expression of
uncertainty in measurement: 1993, shall be used as the basis for expression
of uncertainty of the measurement. NIST Technical Note 1297; January
1993, Guidelines for Evaluating and Expressing the Uncertainty of NIST
Measurement Results, is a practical application document written around the
Guide to the expression of uncertainty in measurement. Where detailed
procedures are not used to quantify and combine uncertainties (i.e., use of
test accuracy ratio concepts), the sources of uncertainty shall be tabulated
and demonstrated to be acceptable for the measurement undertaken.

NOTE: A significant number of intrinsic standards, such as the Josephson
Array Voltage Standard and the lodine-Stabilized Helium-Neon Laser Length
Standard, have been developed and are now being used by many national
standards laboratories and some industrial laboratories. These standards are
based on well-characterized laws of physics, fundamental constants of
nature, or invariant properties of materials, and make ideal stable, precise,
and accurate measurement standards if properly designed, characterized,
operated, monitored and maintained. Where intrinsic standards are used, the
laboratory should demonstrate by measurement assurance techniques,
interlaboratory comparisons, or other suitable means, that its intrinsic
standard measurement results are correlated with those of national or
international standards.

NIST Handbook 150-18 B-13 August 1996


4.17 Dimensions of fasteners - flange screw heads and flange nuts
4.18 Dimensions of fasteners - straightness
4.19 Dimensions of fasteners - bearing surface squareness

4.20 Surface texture

5. CHEMICAL ANALYSIS
5.1 Solution chemical analysis
5.2 Combustion analysis for carbon, sulfur, oxygen, nitrogen, and hydrogen
5.3. Optical emission spectrochemical analysis
5.4 X-ray fluorescence (XRF) spectrochemical analysis
5.5 Energy dispersive X-ray analysis

5.6 Spot test analysis

NIST Handbook 150-18 E-7 August 1996


Phone: (301) 975-4016
Fax: (301) 926-2884
E-mail: nvlap@nist.gov;

(b) Fastener Quality Act, Public Law 101-592,
1990; available from depository libraries of the
United States or a local public library;

(c) Procedures for Implementation of the Fastener
Quality Act, Title 15, Part 280 of the U.S. Code of
Federal Regulations (CFR); available from:

Superintendent of Documents
U.S. Government Printing Office (GPO)
Washington, DC 20402

Phone: (202) 512-1800
Fax: (202) 512-2250;

(d) National Technology Transfer and Advancement
Act of 1995, Public Law 104-113; available from
U.S. Government Printing Office (GPO)—see address
above.

Sec. 285.5 Definitions

Accuracy of measurement: Closeness of the
agreement between the result of a measurement and
a true value of the measureand. [Jnternational
Vocabulary of Basic and General Terms in Metrology
(VIM), 3.5]

Consensus standards organization: The American
Society for Testing and Materials (ASTM), American
National Standards Institute (ANSI), American
Society of Mechanical Engineers (ASME), Society of
Automotive Engineers (ASE), or any other consensus
standards setting organization (domestic or foreign)
determined by the Secretary of Commerce to have
comparable knowledge, expertise, and concern for
the health and safety in the field for which such
organization purports to set standards. [15 CFR Part
280, Sec. 280.2]

Date of manufacture: The date upon which the
initial conversion of material into a fastener takes
place. [15 CFR Part 280, Sec. 280.2]

Fastener: Any screw, nut, bolt or stud, washer or
other item included within the definition for fastener
contained in section 3(5) of the Fastener Quality Act.
The term fastener does not include a screw, nut, bolt,
or stud:

(1) that is produced and marked as ASTM
A307 Grade A;

(2) that is produced in accordance with ASTM
F432; or

(3) that is held out as being produced to other
than the provisions of a document published by a
consensus standards organization, or a government
agency.

A screw, nut, bolt, stud or washer held out as being
produced according to requirements of a document
other than a document published by a consensus
standards organization is a fastener within the
meaning of the Act and this part if that document
incorporates or references (directly or indirectly)
standards and specifications published by a consensus
standards organization or government agency for
purposes of delineating performance or materials
characteristics of the fastener. [15 CFR Part 280,
Sec. 280.2]

Original Laboratory Testing Report: A laboratory
testing report which is originally signed by an
Approved Signatory or is a copy thereof, certified by
the laboratory that conducted the test. [15 CFR Part
280, Sec. 280.2]

Standard Reference Material (SRM): A reference
material certified and distributed by the National
Institute of Standards and Technology (NIST).

Standards and specifications: The provisions of a
document published by a consensus standards
organization, or a government agency. [15 CFR Part
280, Sec. 280.2]

Tamper-resistant system: The use of special paper
or embossing stamps or other controls which
discourage, prevent or minimize alteration of test
reports subsequent to manufacturing, inspection and
testing. [15 CFR Part 280, Sec. 280.2]

Sec. 285.6 NVLAP documentation

Checklists contain definitive statements or questions
about all aspects of the NVLAP criteria for
accreditation. NVLAP programs incorporate two
types of checklists:

(a) The NVLAP General Operations Checklist
addresses factors applicable to evaluating a
laboratory’s ability to conduct testing in accordance
with the procedures and general requirements for
accreditation. The factors include, but are not
limited to, the laboratory’s organization,

NIST Handbook 150-18

August 1996


NVLAP LAB CODE:

(iv)

(vi)

(vii)

(viii)

(ix)

(x)

(xi)

specify and document the responsibility, authority and interrelation of all
personnel who manage, perform or verify work affecting the quality of
calibrations and tests;

provide supervision by persons familiar with the calibration or test methods
and procedures, the objective of the calibration or test, and the assessment
of the results. The ratio of supervisory to non-supervisory personnel shall be
such as to ensure adequate supervision;

have a technical manager (however named) who has overall responsibility for
the technical operations;

Name of person:

have a quality manager (however named) who has responsibility for the
quality system and its implementation. The quality manager shall have direct
access to the highest level of management at which decisions are taken on
laboratory policy or resources, and to the technical manager. In some
laboratories, the quality manager may also be the technical manager or
deputy technical manager;

Name of person:

nominate deputylies) in case of absence of the technical or quality manager;

Name(s):

have documented policy and procedures to ensure the protection of clients’
confidential information and proprietary rights [see also (c)(2)(xviii)];

where appropriate, participate in interlaboratory comparisons and proficiency
testing programs [see also (c)(2)(xiv), (c)(6){ii), (g)(3)];

have documented policy and procedures to ensure that its clients are served
with impartiality and integrity.

(c) Quality system, audit and review

(1)

(i)

The laboratory shall:

have an established and maintained quality system appropriate to the type,
range and volume of calibration and testing activities it undertakes;

NIST Handbook 150-18 B-4 August 1996


APPENDIX D

ON-SITE ASSESSMENT - TEST METHOD REVIEW

NIST Handbook 150-18 D-1 August 1996


1.17

1.20

1.21

Screw tests

1.15.1 Clamp load test

1.15.2 Drill-drive test

1.15.3 Drive test

1.15.4 Ductility test of thread rolling and self-drilling tapping screws

1.15.5 Proof torque test

1.15.6 Torsional strength test of thread rolling and self-drilling tapping screws

Shear

1.16.1 Single shear of externally threaded fasteners
1.16.2 Double shear of externally threaded fasteners
Stress Rupture

Stress rupture of fasteners

Tensile

1.18.1 Axial tensile strength of full-size threaded fasteners

1.18.2 Breaking strength of full-size eyebolts

1.18.3 Tension testing of machined specimens from externally threaded fasteners
1.18.4 Total extension at fracture of externally threaded fasteners

1.18.5 Wedge tensile strength of full-size threaded fasteners

1.18.6 Yield strength of full-size externally threaded fasteners

Torque/tension

1.19.1 Torque-tension of full-size threaded fasteners
1.19.2 Recess strength test in both the installation and removal directions

Vibration

Vibration of full-size threaded fasteners

Washer tests

1.21.1 Compression load of compressible-washer-type direct tension indicators
1.21.2 Embrittlement test of washers

1.21.3 Recovery test of washers

1.21.4 Temper test of lock washers
1.21.5 Twist test of lock washers

2. METALLOGRAPHY

24

2.2

Decarburization and case depth measurement in fasteners

Determination of grain size of fasteners

NIST Handbook 150-18 ES August 1996


NVLAP LAB CODE:

(k) Certificates and reports

(1)

(2)
(i)

(ii)

(iii)

(iv)

{v)

(vi)

(vii)

(viii)

(ix)

The results of each calibration, test, or series of calibrations or tests carried
out by the laboratory shall be reported accurately, clearly, unambiguously
and objectively, in accordance with any instructions in the calibration or test
methods. The results should normally be reported in a calibration certificate,
test report or test certificate and should include all the information necessary
for the interpretation of the calibration or test results and all information
required by the method used [see also (k)(4)(i)].

NOTE: It is recognized that the results of each calibration do not always

result in the production of a calibration certificate or report. Whenever a
certificate or report is produced, the above requirements shall be met.

Each certificate or report shall include at least the following information:
a title, e.g., "Calibration Certificate," "Test Report" or "Test Certificate";

name and address of laboratory, and location where the calibration or test
was carried out if different from the address of the laboratory;

unique identification of the certificate or report (such as serial number) and of
each page, and the total number of pages;

name and address of client, where appropriate;

description and unambiguous identification of the item calibrated or tested
[see also (i)(1)];

characterization and condition of the calibration or test item;

date of receipt of calibration or test item and date(s) of performance of
calibration or test, where appropriate;

EXCEPTION: Although it is encouraged as good laboratory practice, the
requirement for inclusion of the date received is not mandatory for calibration
laboratories.

identification of the calibration or test method used, or unambiguous
description of any non-standard method used;

reference to sampling procedure, where relevant [see also (h)(5)];

NIST Handbook 150-18 B-21 August 1996


NVLAP LAB CODE:

(x) any deviations from, additions to or exclusions from the calibration or test
method, and any other information relevant to a specific calibration or test,
such as environmental conditions [see also (c)(2){xv), (h)(4)];

(xi) measurements, examinations and derived results, supported by tables,
graphs, sketches and photographs as appropriate, and any failures identified;

(xii) a statement of the estimated uncertainty of the calibration or test result,
where relevant;

(xiii) a signature and title, or an equivalent identification of the person(s) accepting
responsibility for the content of the certificate or report (however produced),
and date of issue [see also (c)(2){vi)];

(xiv) where relevant, a statement to the effect that the results relate only to the
items calibrated or tested;

(xv) a statement that the certificate or report shall not be reproduced except in
full, without the written approval of the laboratory;

(xvi) a statement that the report must not be used by the client to claim product
endorsement by NVLAP or any agency of the U.S. Government;

{xvii) the signature of an approved signatory for all test and calibration reports
endorsed with the NVLAP logo;

(xviii) special limitations of use; and

(xix) traceability statement.

(3) Where the certificate or report contains results of calibrations or tests
performed by subcontractors, these results shall be clearly identified
[see also (I)].

NIST Handbook 150-18 B-22 August 1996


NVLAP LAB CODE:

10.1.2

10.1.

10.1.4

10.1.5

Sampling information, including;

standard or reference for sampling scheme;

production lot size and the number sampled and tested;
name and affiliation of person performing the lot sampling.

Test results, including;

actual tests required by standard and specification;

test results for each sample;

all deviations from the test method;

all other items required on test reports according to the test method;
where the report contains results of tests performed by
subcontractors, these results shall be clearly identified along with the
name of the laboratory and accreditation information listed in item
10.1.5 of this checklist;

astatement that the samples tested either conform or do not conform
to the fastener standards and specifications and explanation of any
nonconformance, except as provided for in sections 280.14 and
280.15 of Title 15, Part 280 of the Code of Federal Regulations.

The name, title and signature of Approved Signatory accepting
technical responsibility for the tests and test report.

The name of the body which accredited the laboratory (i.e., NVLAP)
for the specific tests performed which are the subject of the report,
NVLAP Lab Code assigned to the laboratory, and the expiration of
accreditation.

10.2 In addition to the requirements in the General Operations Checklist, for

alternative chemical tests carried out under the Fastener Quality Act, the laboratory
shall provide to the fastener manufacturer, either directly or through the metal
manufacturer, a written inspection and testing report containing the following

information:
10.2.1

10.2.2

Coil or heat number of metal being tested.

Test results, including:

actual tests required by standard and specification;

test results for each sample;

all deviations from the test method;

all other items required on test reports according to the test method;
where the report contains results of tests performed by
subcontractors, these results shall be clearly identified along with the
name of the laboratory and accreditation information listed in item
10.2.4 of this checklist; and

astatement that the samples tested either conform or do not conform
to the metal standards and specifications and explanation of any
nonconformance.

NIST Handbook 150-18

C-6 August 1996


NVLAP LAB CODE:

(3) The laboratory shall provide facilities for the effective monitoring, contro! and
recording of environmental conditions as appropriate. Due attention shall be
paid, for example, to biological sterility, dust, electromagnetic interference,
humidity, voltage, temperature, and sound and vibration levels, as
appropriate to the calibrations or tests concerned.

(4) There shall be effective separation between neighboring areas when the
activities therein are incompatible.

(5) Access to and use of all areas affecting the quality of these activities shall be
defined and controlled.

(6) Adequate measures shall be taken to ensure good housekeeping in the
laboratory.

NOTE: While it is the laboratory’s responsibility to comply with relevant
health and safety requirements, this is outside the scope of this assessment.

NIST Handbook 150-18 B-10 August 1996


NVLAP LAB CODE:

SPECIFIC OPERATIONS CHECKLIST - COMMENTS AND DEFICIENCIES

Instructions to the Assessor: Use this sheet to document comments and deficiencies. For
each, identify the appropriate item number from the checklist. Identify comments with a "C"
and deficiencies with an "X." If additional space is needed, make copies of this page (or use
additional blank sheets).

Item No. Comments and/or Deficiencies

NIST Handbook 150-18 C9 August 1996


2.3

2.4

2.5

2.6

Macroscopic examination of fasteners by etching
Microscopic examination of fasteners by etching
Surface discontinuities of externally threaded fasteners

Surface discontinuities of internally threaded fasteners (nuts)

3. NONDESTRUCTIVE INSPECTION

3.1

3.2

Liquid penetrant inspection of fasteners

Magnetic particle inspection of fasteners

4. DIMENSIONAL INSPECTION

41

4.2

4.3

44

45

4.6

47

4.8

4.9

4.10

4.11

4.12

4.13

4.14

4.15

4.16

External thread parameters - system 21

External thread parameters - system 22

External thread parameters - system 23

External thread parameters - SAE fastener with MJ metric screw threads
External thread parameters - ISO

Internal thread parameters - system 21

Internal thread parameters - system 22

Internal thread parameters - system 23

Internal thread parameters - SAE fastener with MJ metric screw threads
Internal thread parameters - ISO

Dimensions of general purpose fasteners and high-volume machine assembly fasteners

Dimensions of special purpose fasteners and fasteners for highly specialized engineered
applications

Dimensions of ISO grade A and B fasteners
Dimensions of ISO grade C fasteners
Dimensions of fasteners - hexagon and double hexagon (12 point) and spline sockets

Dimensions of fasteners - gaging for slotted nuts

NIST Handbook 150-18 E-6 August 1996


ACKNOWLEDGMENTS

Thanks are due to all those who contributed to the contents of this handbook. The experience and
knowledge gained since the inception of the Fastener Quality Act dictated that we completely revise the
draft handbook to reflect new requirements and information.

Special recognition is due Wayne Stiefel, who compiled and edited the initial draft of this handbook.
Additional acknowledgment is due to the many people and NVLAP technical experts who provided
helpful comments and suggestions to develop the program. Also, thanks are extended to Vanda R.
White, whose efforts brought this handbook to fruition.


vvvvYVYVYYVYVYYVVYVY vv vv vv VV VV VV VV VV YY

NVLAP LAB CODE:

(2)

(i)

(ii)

(iii)

(iv)

g

(vi)

Detailed requirements for M & TE

Calibration system description: The supplier shall provide and maintain a
written description of the calibration/verification system covering M & TE
and measurement standards. The description shall be sufficient to satisfy
each requirement of section 285.33(0) and any deviations shall be submitted
with supporting documentation to the customer for approval.

Adequacy of measurement standards: Measurement standards used by the
supplier for calibrating M & TE and other measurement standards shall
comply with the requirements of items (f)(1), (g)(1), and (h)(2).

Environmental conditions: M & TE shall be used in an environment
controlled to the extent necessary to ensure valid results. Due consideration
shall be given to temperature, humidity, lighting, vibration, dust control,
cleanliness, electromagnetic interference and any other factors affecting the
results of measurements. Where pertinent, these factors shall be monitored
and recorded and, when appropriate, correcting compensations shall be
applied to measurement results.

Intervals of calibration and verification: M & TE requiring calibration shall be
calibrated or verified at periodic intervals established and maintained to
assure acceptable reliability, where reliability is defined as the probability that
M & TE will remain in-tolerance throughout the interval. Intervals shall be
established for all M & TE requiring calibration unless the equipment is
regularly monitored through the use of check standards in a documented
measurement assurance process. Check standards must closely represent
the item parameters normally tested in the process and the check standard
must be verified periodically. Where intervals are used to ensure reliability,
the interval setting system must be systematically applied and shall have
stated reliability goals and a method of verifying that the goals are being
attained. Intervals may be based on usage or time since last calibration or
verification. All exemptions from periodic calibration or verification shall be
documented. The recall system may provide for the temporary extension of
the calibration due date for limited periods of time under specified conditions
that do not unreasonably impair the satisfaction of the customer’s
requirements.

Calibration procedures: Procedures used to calibrate/verify the supplier's
M & TE shall comply with the requirements of items (h)(1) and (h)(2).

Out-of-tolerance conditions: If any M & TE is found to be significantly out of
tolerance during the calibration/verification process, the supplier’s system
shall provide for notification to the user and to the supplier’s quality element,
if appropriate, of the out-of-tolerance condition with the associated
measurement data so that appropriate action can be taken.

NIST Handbook 150-18 B-29 August 1996


NVLAP LAB CODE:

(2) Where no independent assurance of the quality of outside support services
or supplies is available, the laboratory shall have procedures to ensure that
purchased equipment, materials and services comply with specified
requirements. The laboratory should, wherever possible, ensure that
purchased equipment and consumable materials are not used until they have
been inspected, calibrated or otherwise verified as complying with any
standard specifications relevant to the calibrations or tests concerned [see
also (h)(8)].

(3) The laboratory shall maintain records of all suppliers from whom it obtains
support services or supplies required for calibrations or tests.

({n) Complaints [see also (c)(2)(xvii)]

(1) The laboratory shall have documented policy and procedures for the
resolution of complaints received from clients or other parties about the
laboratory's activities. A record shall be maintained of all complaints and of
the actions taken by the laboratory.

(2) Where a complaint, or any other circumstance, raises doubt concerning the
laboratory’s compliance with the laboratory's policies or procedures, or with
the NVLAP requirements or otherwise concerning the quality of the
laboratory’s calibrations or tests, the laboratory shall ensure that those areas
of activity and responsibility involved are promptly audited in accordance
with item (c)(3).

NIST Handbook 150-18 B-27 August 1996


nonconformance, except as
provided for in sections 280.14 and
280.15 of 15 CFR Part 280.

(iv) Name, title and signature of
Approved Signatory accepting technical
responsibility for the tests and test report.

(v) The name of the body which
accredited the laboratory (i.e., National
Voluntary Laboratory Accreditation
Program) for the specific tests performed
which are the subject of the report,
NVLAP Lab Code assigned to the
laboratory, and the expiration of
accreditation. [Note: NVLAP procedures
must be followed when referencing the
term NVLAP and using the NVLAP logo;
see NIST Handbook 150, Sec. 285.8.]

(2) In addition to the requirements found in
Sec. 285.33(k) of NIST Handbook 150, for
alternative chemical tests carried out under the
Fastener Quality Act, the laboratory shall
provide to the fastener manufacturer, either
directly or through the metal manufacturer, a
written inspection and testing report containing
” the following information:

@ Coil or heat number of metal being
tested.

Gi) Test results:

* Actual tests
specification;

© Test results for each sample;

¢ All deviations from the test
method;

¢ All other items required on test
reports according to the test
method;

© Where the report contains results of
tests performed by subcontractors,
these results shall be clearly
identified along with the name of
the laboratory and accreditation
information listed in item (iv) of
this section;

¢ A statement that the samples tested.
either conform or do not conform
to the metal specifications or
standards and explanation of any
nonconformance.

required by

oO

(iii) Name, title and signature of
Approved Signatory accepting technical
responsibility for the tests and test report.

(iv) The name of the body which
accredited the laboratory (i.e., National
Voluntary Laboratory Accreditation
Program) for the specific tests performed
which are the subject of the report,
NVLAP Lab Code assigned to the
laboratory, and the expiration of
accreditation. [Note: NVLAP procedures
must be followed when referencing the
term NVLAP and using the NVLAP logo;
see NIST Handbook 150, Sec. 285.8.]

(3) The laboratory shall issue corrections or
additions to a test report only by a further
document suitably marked; e.g., "Supplement to
test report serial number . . . .". This document
must specify which test result is in question, the
content of the result, the explanation of the
tesult, and the reason for acceptance of the
Tesult.

Subcontracting of calibration or testing

(1) Whenever a laboratory performs work
under the provisions of the Fastener Quality
Act, it is implied that the report reflects work
performed, and results obtained, by the
personnel, equipment, and procedures of that
laboratory. However, in some cases a
laboratory may require the use of another
facility due to equipment failure, need for
specialized equipment, work overload, or to
perform tests outside the laboratory’s own scope
of accreditation.

(2) Whenever a laboratory subcontracts to
another laboratory the performance of any test
or portion of a test it must:

@ place the work with another
laboratory accredited under the provisions
of the Fastener Quality Act;

(ii) inform the client, before the fact,
that subcontracting will be necessary; and

(iii) clearly identify in its records, and
in the report to the client, specifically
which test method(s) or portions of a test
method(s) were performed by _ the

NIST Handbook 150-18

August 1996


NVLAP LAB CODE:

SPECIFIC OPERATIONS CHECKLIST - COMMENTS AND DEFICIENCIES

Instructions to the Assessor: Use this sheet to document comments and deficiencies. For
each, identify the appropriate item number from the checklist. Identify comments witha "C"
and deficiencies with an "X." If additional space is needed, make copies of this page (or use

additional blank sheets).

Item No. Comments and/or Deficiencies

NIST Handbook 150-18 C-8 August 1996


APPENDIX E

MAJOR AREAS OF TESTING

NIST Handbook 150-18 E-l August 1996


APPENDIX A

SAMPLE ACCREDITATION DOCUMENTS

NIST Handbook 150-18 A-l August 1996


PREFACE

NIST Handbook 150-18 presents the technical requirements of the National Voluntary Laboratory
Accreditation Program (NVLAP) for accreditation of laboratories under the Fasteners and Metals
program. It is intended for information and use by staff of accredited laboratories, those laboratories
seeking accreditation, other laboratory accreditation systems, users of laboratory services, and others
needing information on the accreditation requirements.

This publication supplements the Fastener Quality Act (PL 101-592) as amended by the National
Technology Transfer and Advancement Act (PL 104-113) and its implementing regulations as described
in Title 15, Part 280 of the U.S. Code of Federal Regulations, and NIST Handbook 150, NVLAP
Procedures and General Requirements (which contains all general NVLAP procedures, criteria, and
policies).

The criteria in NIST Handbook 150 encompass the requirements of ISO/IEC Guide 25:1990 and the
relevant requirements of ISO 9002 (ANSI/ASQC Q92-1987). The provisions of NIST Handbook 150
shall remain in effect for this accreditation program except as superseded by PL 101-592 and its
implementing regulations and documented in this handbook.

The numbering of the sections of NIST Handbook 150-18 is patterned after NIST Handbook 150; for
example, Section 285.3 of Handbook 150 presents the description and goal of NVLAP, whereas Section
285.3 of Handbook 150-18 presents the description of the Fasteners and Metals accreditation program.
Where the material in Handbook 150 is not specific to the Fasteners and Metals program, the section
number is omitted.

Any questions or comments on this handbook should be submitted to the National Institute of Standards

and Technology/NVLAP, Building 820, Room 282, Gaithersburg, MD 20899; phone (301) 975-4016;
fax (301) 926-2884; e-mail NVLAP@nist.gov.

iii


vvrvy

NVLAP LAB CODE:

(j) Records

(1) The laboratory shall maintain a record system to suit its particular
circumstances and comply with any applicable regulations. It shall retain on
record all original observations, calculations and derived data, calibration
records and a copy of the calibration certificate, test certificate or test report
for an appropriate period. The records for each calibration and test shall
contain sufficient information to permit their repetition. The records shall
include the identity of personnel involved in sampling, preparation, calibration
or testing [see also (c){2){iv)].

EXCEPTION: The retention of all original observations, calculations, and
derived data in the calibration record system is not a mandatory requirement
for calibration laboratories, although it is encouraged as good laboratory
practice.

(2) All records (including those listed in (f)(4) pertaining to calibration and test
equipment), certificates and reports shall be safely stored, held secure and in
confidence to the client [see also (b)(2){ix), (c)(2)(xviii)].

NOTE: The period of retention shall be specified in the quality manual.

Record retention time specified:

NIST Handbook 150-18 B-20 August 1996


NVLAP LAB CODE:

(6)

(i)

{ii)

(iii)

(iv)
(v)

(vi)

In addition to periodic audits the laboratory shall ensure the quality of results
provided to clients by implementing checks. These checks shall be reviewed
and shall include, as appropriate, but not be limited to:

internal quality control plans, such as control charts and other available
statistical techniques;

NOTE: Measurement assurance techniques are acceptable means to control
the measurement process and consistently produce the highest quality
measurements.

participation in proficiency testing or other interlaboratory comparisons [see
also (b)(2)(x), (c)(2)(xiv), (g)(3)];

regular use of certified reference materials and/or in-house quality control
using secondary reference materials;

replicate testings using the same or different methods;
retesting of retained items;

correlation of results for different characteristics of an item.

(d) Personnel [see also (c)(2)(v)]

(1)

(2)

The testing laboratory shall have sufficient personnel, having the necessary
education, training, technical knowledge and experience for their assigned
functions.

The testing laboratory shall ensure that the training of its personnel is kept
up-to-date.

NIST Handbook 150-18 B-S& August 1996


National Institute of Standards and Technology
NIST Handbook 150-18

68 pages (August 1996)

CODEN: NIHAE2

U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON: 1996

For sale by the Superintendent of Documents
U.S. Government Printing Office
Washington, DC 20402-9325

NVLAP AND THE NVLAP LOGO

The term NVLAP and the NVLAP logo are
Federally registered trademarks of the National
Institute of Standards and Technology and the
Federal Government, who retain exclusive rights
therein. Permission to use the term and/or the logo
is granted to NVLAP-accredited laboratories for the
limited purposes of announcing their accredited
status, and for use on reports that describe only
testing and calibration within the scope of
accreditation. NIST reserves the right to control
the quality of the use of the term NVLAP and of
the logo itself.


NVLAP LAB CODE:

GENERAL OPERATIONS CHECKLIST - COMMENTS AND DEFICIENCIES

Instructions to the Assessor: Use this sheet to document comments and deficiencies. For
each, identify the appropriate item number from the checklist. Identify comments with a
"C" and deficiencies with an "X." If additional space is needed, make copies of this page
{or use additional blank sheets).

Item No. Comments and/or Deficiencies

NIST Handbook 150-18 B-32 August 1996


vvVYvVYVYYVYYYVYYVY YY v vv

NVLAP LAB CODE:

(2)

(3)

The laboratory shall use appropriate methods and procedures for all
calibrations and tests and related activities within its responsibility (including
sampling, handling, transport and storage, preparation of items, estimation of
uncertainty of measurement and analysis of calibration and/or test data).
They shall be consistent with the accuracy required, and with any standard
specifications relevant to the calibrations or tests concerned.

NOTES:

(i) Calibration procedures shall contain the required range and tolerance or
uncertainty of each item or unit parameter being calibrated or verified.
In addition, the procedures shall contain the generic description of the
measurement standards and equipment needed with the required
parameter, range, tolerances or uncertainties, and specifications for
performing the measurement of the calibration or verification, and/or
representative types (manufacturer, model, option) that are capable of
meeting the generic description for the measurement standards. The
procedures shall be consistent with the accuracy required, and with
any standard specifications relevant to the calibrations/verifications
concerned.

(ii) | The laboratory shall ensure that the calibration uncertainties are
sufficiently small so that the adequacy of the measurement is not
affected. Well-defined and documented measurement assurance
techniques or uncertainty analyses may be used to verify the adequacy
of a measurement process. If such techniques are not used, then the
collective uncertainty of the measurement standards shall not exceed
25% of the acceptable tolerance (e.g., manufacturer’s specification) for
each characteristic of the measuring and test equipment being
calibrated or verified.

Where methods are not specified, the laboratory shall, wherever possible,
select methods that have been published in international or national
standards, those published by reputable technical organizations or in relevant
scientific texts or journals.

NIST Handbook 150-18 B-16 August 1996


NVLAP LAB CODE:

(l) Subcontracting of calibration or testing [see also (k)(3)]

(1)

(2)

(3)

(i)

(ii)

(iii)

(iv)

Where a laboratory subcontracts any part of the calibration or testing, this
work shall be placed with a laboratory complying with these requirements.
The laboratory shall ensure and be able to demonstrate that its subcontractor
is competent to perform the activities in question and complies with the
same criteria of competence as the laboratory in respect of the work being
subcontracted. The laboratory shall advise the client in writing of its
intention to subcontract any portion of the testing to another party.

The laboratory shall record and retain details of its investigation of the
competence and compliance of its subcontractors and maintain a register of
all subcontracting.

A NVLAP-accredited laboratory intending to subcontract testing or calibration
work that will be performed and reported as meeting NVLAP procedures and
criteria must:

have in its quality manual a subcontracting policy compatible with the
NVLAP policy, with a description of the procedures for administering and
implementing those actions to demonstrate the conformance and consistency
of the subcontracted laboratory to perform according to NVLAP procedures;

place the subcontracted work with a laboratory that maintains accreditation
established by NVLAP shown by a current NVLAP Lab Code, or provide and
maintain current records that demonstrate that the subcontracted laboratory
is competent to perform the test(s) or calibration(s) and that it operates in a
manner consistent with and in conformance to NVLAP criteria for
accreditation;

clearly identify in its records, and in the report to the client, exactly which
data were obtained by the NVLAP-accredited laboratory and which data were
obtained by the subcontractor, NVLAP-accredited or not;

inform its client, before the fact, that it intends to subcontract for completion
of all or a portion of the client’s work; and

NIST Handbook 150-18 B-25 August 1996


NVLAP LAB CODE:

(f) Equipment and reference materials

(1)

(i)

(ii)

(2)

(3)

(4)

(i)

The laboratory shall:

be furnished with all items of equipment (including hardware, software, and
reference materials) required for the correct performance of calibrations and
tests;

in those cases where the laboratory needs to use equipment outside its
permanent control, including rented, leased and client-owned equipment,
ensure that the relevant NVLAP requirements are met.

All equipment shall be properly maintained. Maintenance procedures shall be
documented. Any item of the equipment which has been subjected to
overloading or mishandling, or which gives suspect results, or has been
shown by verification or otherwise to be defective, shall be taken out of
service, clearly identified and wherever possible stored at a specified place
until it has been repaired and shown by calibration, verification or test to
perform satisfactorily. The laboratory shall examine the effect of this defect
on previous calibrations or tests.

Each item of equipment including reference materials shall, when
appropriate, be labelled, marked or otherwise identified to indicate its
calibration status.

Records shall be maintained of each item of equipment and all reference
materials significant to the calibrations or tests performed. The records shall
include:

the name of the item of equipment, software or reference material;

NIST Handbook 150-18 B-1l August 1996


(h)

standards authority that issues reference or
calibration materials. It is the responsibility of
the laboratory seeking accreditation to determine
that, where appropriate, calibration services use
reference standards traceable to NIST or to a
foreign national standards authority.

(2) Calibration certificates and records and
evidence of the traceability of the reference
standards used must be retained and made
available for an assessor’s inspection during the
on-site visit. The calibration certificate should
indicate uncertainty or accuracy tolerance limits,
and traceability of reference standards. If
calibration is performed by the laboratory, the
standard metrological procedures used, the
environmental conditions, and the measurement
uncertainty must be documented. Certificates
are required for calibration performed by
outside services; they are not required for all
testing equipment.

The records for each calibration and test shall
contain sufficient information to permit their
Tepetition. The records shall include the
identity of personnel involved in sampling,
preparation, calibration or testing.

(3) In addition to the information specified in
NIST Handbook 150, Sec. 285.33(f)(4), testing
equipment or verification records shall include
the following:

(0) notation of all equipment variables
requiring verification;

(ii) the range of verification;

(iii) _ the resolution of the instrument and
its allowable error;

(iv) identity of the laboratory individual
or external service responsible for
calibration; and

(v) source of reference standard and
traceability.

Calibration and test methods

(1) Laboratories shall use standards and
specifications which are published by a
consensus standards organization or by a
government agency in the areas of chemical
analysis, dimensional inspection, mechanical and

physical testing and inspection, metallography,
and nondestructive inspection. The laboratory
must have a copy of all standards, test methods,
or specifications for which it seeks
accreditation.

(2) Testing conducted in the Fasteners and
Metals program is divided into five major areas
of testing:

w@ mechanical and physical testing and
inspection;

(ii) metallography;

(iii) nondestructive inspection;
(iv) dimensional inspection; and
(v) chemical analysis.

Each of these major areas is further divided into
test groups with the mechanical and physical
testing area further divided into subgroups.
Individual standards, test methods, and
specifications fall under the test groups or
subgroups.

A breakdown of the five major areas is provided
in Appendix E.

(3) The laboratory shall conform in all
respects with the standard, test method, or
specification except when a departure becomes
necessary for technical reasons. Laboratories
utilizing departures from a test method shall
have written procedures detailing how the
analysis is conducted. These procedures shall
include criteria to determine when such
departures are warranted. The laboratory shall
have data to demonstrate that departures do not
detract from the expected precision and
accuracy of a measurement. Departures shall
be acceptable to the client.

(4) Laboratories will be granted accreditation
only for the standards, test methods, or
specifications for which they apply and are
competent to perform under NVLAP criteria.

(5) Where a standard, test method, or
specification does not adequately cover all
aspects of testing (i.e., sampling, sample
preparation, etc.) the laboratory shall have

NIST Handbook 150-18

August 1996


1.6

1.7

1.8

1.9

1,10

1.12

Elevated temperature testing

Elevated temperature testing capability

Embrittlement

1.7.1 Hydrogen embrittlement (stress durability) of externally threaded fasteners
1.7.2 Hydrogen embrittlement (stress durability) of internally threaded fasteners (nuts)
1.7.3 Test for embrittlement of metallic coated externally threaded fasteners
Fatigue

Fatigue of full-size threaded fasteners

Hardness

1.9.1 Brinell hardness of fasteners

1.9.2 Microhardness of fasteners

1.9.3 Rockwell hardness of fasteners

1.9.4 Rockwell superficial hardness of fasteners

1.9.5 Vickers hardness - test forces from 9.807 to 1176 N (1 to 120 kgf)

Impact

1.10.1 Charpy impact (v-notch) testing
1.10.2 Charpy impact (u-notch) testing

Magnetic permeability

Magnetic permeability of fasteners using a low-mu permeability indicator
Prevailing torque

Prevailing torque of full-size prevailing-torque type nuts

Proof

1.13.1 Cone proof load of internally threaded fasteners (nuts)

1.13.2 Proof load of full-size externally threaded fasteners

1.13.3 Proof load of full-size eyebolts

1.13.4 Proof load of internally threaded fasteners (nuts)

Rotational capacity

Rotational capacity of full-size threaded fasteners

NIST Handbook 150-18 E-4 August 1996


APPENDIX C

SPECIFIC OPERATIONS CHECKLIST

NIST Handbook 150-18 Cl August 1996


NVLAP LAB CODE:

1. staff member’s title and description of that job position;
2 job and quality assurance responsibilities;

3 résumé;

4 training;
5
6

assigned laboratory procedures and duties; and
results of periodic testing performance reviews.

3.3 The laboratory shall have a description of its staff training program including its
criteria for successful completion.

3.4 Analysts and technical supervisors shall participate in some form of continuing
education, such as formal course work, in-house education, and scientific or technical
meetings, and have access to journals that describe advances in their field of testing.
4 Accommodation (facilities) and environment
(See General Operations Checklist.)
5 Equipment and reference materials
(See General Operations Checklist.)

6 Measurement traceability and calibration

6.1 Calibrations are performed by properly trained staff using calibrated standards
traceable to NIST, or by using a NVLAP-accredited calibration laboratory.

7 Test methods and calibration
(See General Operations Checklist.)
8 Handling of calibration and test items

8.1 The laboratory shall have a sample log system used to uniquely identify the test
item and document the action. The log shall include:

.1.1 date of receipt of the test item;

-1.2 the condition of the test item;

.1.3. documentation of acceptance or rejection of test item, reasons for
rejection;

a unique laboratory identification number for each test sample;

the client identification number, which is the number that the client (or
sample taker) assigns to the test item;

8.1.6 the initials of the person making the above entries in the sample log
book.

oo 0 0

a1.
a1.

© 0
aps

8.2 Where there is any doubt as to the test item’s suitability for testing (e.g., a
mismatch between identification and description, or whether they are of a type which

NIST Handbook 150-18 C-4 August 1996


accredited laboratory and which were
performed by the subcontractor.

(m) Outside support services and supplies
(See NIST Handbook 150.)
() =Complaints

(See NIST Handbook 150.)

NIST Handbook 150-18 10 August 1996